Valved prosthesis with porous substrate

• US 7,371,258 B2
• Filed: 10/26/2001
• Issued: 05/13/2008
• Est. Priority Date: 10/26/2001
• Status: Expired due to Fees

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Pandit, Abhay S., Woo, Yi-Ren
• Primary Examiner(s): SWEET, THOMAS
• Application Number:
  US10/004,504
• Publication Number:
  US 20030083741A1
• Time in Patent Office: 2,391 Days
• Field of Search: 623/2.2, 623/2.21, 623/2.22, 623/2.23, 623/2.24, 623/2.25, 623/2.26, 623/2.27, 623/2.28, 623/2.29, 623/2.3, 623/2.31, 623/2.32, 623/2.33
• US Class Current: 623/2.22
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2406 without fixed axis
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges

Abstract

An implantable prosthesis can be formed from an improved biocompatible material that provides for cellular colonization of the biocompatible material. Specifically, the biocompatible material is a rigid porous material. In embodiments of particular interest, the implantable prosthesis is a mechanical heart valve prosthesis with a rigid occluder. In some embodiments, the rigid occluder is formed from the biocompatible material. A filler comprising a hydrogel or a structural protein can be located within the pores. In some embodiments, a bioactive agent is within the pores. In some embodiments, the rigid occluder is formed from a polymer material, a carbonaceous solid or a ceramic material. The pores can extend through the rigid material.

Claims

1. An implantable prosthesis comprising:

at least one occluder, wherein the at least one occluder comprises a rigid material with pores formed in the rigid material, wherein the rigid material is selected from the group consisting of metals, carbonaceous solids, polymers, and ceramics; and

a filler comprising a hydrogel or a structural protein or a bioactive agent or mixtures thereof, the filler being located within the pores, wherein said rigid porous material with the filler presents a smoother surface for fluid flow than pores without filler and wherein the filler prevents back flow of fluid through the pores of the occluder.

2. The implantable prosthesis of claim 1 wherein the filler fills the pores.

3. The implantable prosthesis of claim 2 wherein the rigid porous material with the filler presents a smooth surface to flow.

4. The implantable prosthesis of claim 1 wherein the filler partly fills the pores.

5. The implantable prosthesis of claim 1 wherein the filler comprises a hydrogel selected from the group consisting of poly(ethylene glycol), poly(hydroxyethyl methacrylate), partially or fully hydrolyzed poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers, polyamines, polyacrylamide, hydroxypropylmethacrylate, carboxymethyl cellulose, hydroxyethyl cellulose, methylhydroxypropyl cellulose, polysucrose, hyaluronic acid, alginate, chitosan, dextran, gelatin and mixtures and copolymers thereof.

6. The implantable prosthesis of claim 1 wherein the filler comprises a structural protein.

7. The implantable prosthesis of claim 6 wherein the structural protein is an extracellular matrix protein.

8. The implantable prosthesis of claim 1 wherein the filler comprises a mixture of hydrogel and structural protein.

9. The implantable prosthesis of claim 1 wherein the filler comprises a biologically active agent.

10. The implantable prosthesis of claim 9 wherein the biologically active agent is dispersed within the hydrogel or protein.

11. The implantable prosthesis of claim 9 wherein the biologically active agent is selected from the group consisting of a growth factor, a cell attraction compound, an anticoagulant and combinations thereof.

12. The implantable prosthesis of claim 9 wherein the biologically active agent is VEGF.

13. The implantable prosthesis of claim 9 wherein the bioactive agent is a growth factor.

14. The implantable prosthesis of claim 9 wherein the bioactive agent is a progenitor attraction compound.

15. The implantable prosthesis of claim 9 wherein the bioactive agent is an anticoagulant.

16. The implantable prosthesis of claim 1 wherein the pores have an interconnecting porosity.

17. The implantable prosthesis of claim 1 wherein a nutrient is also located within the pores.

18. The implantable prosthesis of claim 1 further comprising viable cells.

19. The implantable prosthesis of claim 1 wherein the prosthesis is a mechanical heart valve prosthesis comprising an orifice ring and the at least one occluder attached to the orifice ring.

20. The implantable prosthesis of claim 1 wherein the rigid polymer is selected from the group consisting of polysulfones, polyacetals, polyethersulfones, polyarylsulfones, polyetheretherketones, polyamides, polyurethanes, polytetrafluoroethylene, other fluoronated and perfluoronated vinylpolymers, polycarbonate, polyetherimides, tyrosine-derived polyarylate polymers, polylactic acid and polyglycolic acid-based composites and copolymers and mixtures thereof.

21. The implantable prosthesis of claim 1 and wherein the occluder comprises an upstream side and a downstream side and wherein the occluder comprises a network of interconnected pores that provide a passageway for the fluid from the downstream side to the upstream side and wherein the filler is placed within the pores to prevent the backflow of fluid from the downstream side to the upstream side of the occluder.

22. An implantable medical device comprising;

at least one occluder, wherein the at least one occluder comprises a rigid material having pores formed in the rigid material and present substantially close to a surface of the rigid material, wherein the rigid material is selected from the group consisting of metals, carbonaceous solids, polymers, and ceramics; and

a filler, said filler comprising a hydrogel or a structural protein or a bioactive agent or mixtures thereof, the filler being located within the pores to promote cellular attachment and proliferation and wherein the filler prevents back flow of fluid through the pores of the occluder.

23. The medical device of claim 22 wherein said device is for contacting bodily fluids and/or tissue after implantation.

24. The medical device of claim 22 wherein said filler fills the pores.

25. The medical device of claim 24 wherein said rigid porous material with the filler presents a smooth surface to flow.

26. The medical device of claim 22 wherein said bioactive agent is dispersed within the hydrogel or protein.

27. The medical device of claim 22 wherein the bioactive agent is selected from the group consisting of a growth factor, a cell attraction compound, an anticoagulant and combinations thereof.

28. The medical device of claim 22 wherein the bioactive agent is VEGF.

29. The medical device of claim 22 wherein the bioactive agent is a progenitor attraction compound.

30. The medical device of claim 22 wherein the bioactive agent is an anticoagulant.

31. An implantable medical device comprising;

at least one occluder, wherein the at least one occluder comprises a rigid material having pores substantially extending through the rigid material to form a porous network, wherein the rigid material is selected from the group consisting of metals, carbonaceous solids, polymers, and ceramics; and

a filler, said filler comprising a hydrogel or a structural protein or a bioactive agent or mixtures thereof, the filler being located within the pores, and said porous network does not provide significant blood flow through the porous material and wherein the filler prevents back flow of fluid through the pores of the occluder.

32. The medical device of claim 31 wherein said porous network promotes cellular attachment and proliferation.

33. The medical device of claim 31 wherein said filler fills the pores.

34. The medical device of claim 33 wherein said rigid porous material with the filler presents a smooth surface to flow.

35. The medical device of claim 31 wherein said bioactive agent is dispersed within the hydrogel or protein.

36. The medical device of claim 31 wherein the bioactive agent is selected from the group consisting of a growth factor, a cell attraction compound, an anticoagulant and combinations thereof.

37. The medical device of claim 31 wherein the bioactive agent is VEGF.